1. The Field of the Invention
The present invention relates to a medical device for use in the treatment of hemorrhoid problems.
2. The Prior Art
The veins of the internal rectal plexus often become excessively dilated and inflamed in a condition commonly known as hemorrhoids or piles. This inflammation and swelling of the veins located in the rectum and anus region is due to several factors. One is the vessels are contained in very loose connective tissue. Therefore, the rectal veins receive less support from surrounding tissues and are less able to resist increased blood pressure. Constipation, often the result of poor eating habits, further exacerbates the condition.
While the condition is generally not serious, in a life threatening sense, it is very common and can cause moderate to severe discomfort in patients during episodes in which the veins are particularly swollen. In fact, the defeat of Napoleon by Wellington at Waterloo in 1815 has been attributed, at least in part, to Napoleon's alleged inattention to the battle caused by his suffering from hemorrhoid problems.
Standard treatment consists of the application of creams or ointments, sitz baths, and, in more severe cases, surgical intervention. Further, a number of medical devices have been proposed to augment or supplant the above treatment methods by providing needed support to hold the protruding veins in place while the swelling and inflammation subside thus protecting the area from further injury.
U.S. Pat. No. 702,789 issued to Gibson on Jun. 17, 1902, discloses a dilator formed from a slender tube having longitudinal slits in communication with an internal pear-shaped piston which will cause the diameter of the tube to expand in the region of the piston when it is moved through the tube. The maximum variation of the external geometry of the device is limited by the practical limits of varying the wall thickness of the segmented tube. Further, Gibson does not address the benefits of using such a device for the treatment of hemorrhoids.
U.S. Pat. No. 1,271,456 issued to Flack discloses a rectal dilator which, while it is expansible, would clearly require the assistance of someone to aid the patient in effecting the expansion of the device once it is in place. This is because the device is screw operated and would necessarily have to be held against rotation while the knob 10 is twisted. Clearly this device, as is the case with the above mentioned Gibson device, could not be worn by the patient during the daily routine.
U.S. Pat. No. 1,610,946 issued to Hosmer on Dec. 14, 1926, discloses a medical device (sometimes referred to as a "bougie") for the treatment of the disorder. The device has a rigid conical shape having spiral ridges on its outer surface. This instrument provides no means for adjusting pressure by conveniently changing the geometry of the device during the insertion and/or removal operation.
U.S. Pat. No. 2,653,599 issued to Bell on Sep. 29, 1953, discloses an instrument having a shank of uniform diameter with a partial sphere-structure which is adapted to be inserted into the rectum. The other end is fitted with a stop having the face thereof nearest to the partial sphere of convex shape. Again, no provision is made or suggested for changing the geometry of the device during use to permit easy insertion or removal or to control the pressure applied to the rectal wall.
U.S. Pat. No. 3,675,642 issued to Lord on Jul. 11, 1972, discloses a rectal cone for use in post operative care of hemorrhoidectomy and similar procedures. The cone's maximum diameter is required to be approximately 1.5 inches. Further, the medical instrument has no provision for changing the geometry of the instrument in use.
Various dilating instruments have been designed to stretch or expand tissues or cavities with each instrument specially adapted to its particular function. Representative of the genre is U.S. Pat. No. 4,257,406, which discloses an iris retractor and pupil dilator. This instrument uses a pair of cross-action spring arms designed to expand the pupil to permit removal of the lens without injury to the iris. This instrument is designed for making small tweezer-like movements for use in eye surgery. U.S. Pat. No. 1,928,893 discloses a vaginal and rectal exerciser formed by a pair of semi cylindrical members spring loaded with respect to each other.
U.S. Pat. Nos. 1,244,751; 1,877,766; 1,879,307; 2,443,207; 2,721,549; 3,826,242; and 4,583,542 disclose other variations of instruments designed to treat hemorrhoids and are on general interest.
The prior art does not provide a hemorrhoid instrument that is easily adjusted for insertion and removal yet is capable of providing sufficient pressure to hold protruding hemorrhoids in place while healing occurs.